M2 EQUITYBITES-January 30, 2018-Mylan and Biocon receive positive CHMP opinion for biosimilar insulin glargine
M2 PHARMA-January 30, 2018-Mylan and Biocon receive positive CHMP opinion for biosimilar insulin glargine
announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Semglee, insulin glargine
, a long-acting insulin analog used in the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
DEVOTE is a randomised, multinational and double-blinded trial conducted to confirm the cardiovascular safety of Tresiba, as compared to insulin glargine
U100 when added to standard of care, in people with type 2 diabetes.
This strategy was used to produce insulin glargine
is the drug substance in drugs like Lantus[R] and Toujeo[R] that are produced by Sanofi in Frankfurt and exported to the US, amounting to more than 4 billion USD in 2015 (2).
Since no insulin glargine
products are currently licensed under the Public Health Service Act, there is no reference product for a proposed biosimilar, according to the FDA.
, NPH, and liraglutide, must be injected at the same time of the day, while detemir should be administered at night.
MUNICH - Once-weekly dulaglutide plus insulin glargine
and metformin allowed 69% of patients with poorly controlled type 2 diabetes to achieve a hemoglobin [A.
The patients were divided into 2 groups: subcutaneous insulin glargine
+ IV regular insulin (group 1) or only IV regular insulin (group 2).
Uni-E4 demonstrated significant difference in change of body weight versus insulin glargine
He found that the high level of insulin was a synthetic substance called Lantus insulin glargine
which is not generated by the body, so it must have been administered.